ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4145
Product ID 70518-4145_3fb50021-67ad-645c-e063-6394a90a91b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

Pharmacologic Class

Classes
serotonin 3 receptor antagonists [moa] serotonin-3 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184145
Hyphenated Format 70518-4145

Supplemental Identifiers

RxCUI
198052
UNII
NMH84OZK2B

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ondansetron hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 16 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-1)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-2)
  • 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4145-3)
source: ndc

Packages (4)

70518-4145-0 16 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-0) 70518-4145-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-1) 70518-4145-2 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-2) 70518-4145-3 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4145-3)

Ingredients (1)

ondansetron hydrochloride (4 mg/1)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fb50021-67ad-645c-e063-6394a90a91b0", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052"], "spl_set_id": ["960e2104-18c3-4cfa-abf6-f1b30c452918"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "16 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-0)", "package_ndc": "70518-4145-0", "marketing_start_date": "20240718"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-1)", "package_ndc": "70518-4145-1", "marketing_start_date": "20240718"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4145-2)", "package_ndc": "70518-4145-2", "marketing_start_date": "20241220"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4145-3)", "package_ndc": "70518-4145-3", "marketing_start_date": "20250402"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "70518-4145_3fb50021-67ad-645c-e063-6394a90a91b0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "70518-4145", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}